MILAN, Italy, April 10, 2007 - BioXell S.p.A.
(SWX: BXLN) today reported its financial results for the full year 2006. The year was marked by a successful IPO on the SWX Swiss Exchange in June, raising a total of € 40 million, as well as a private financing round in March which raised an additional € 10.5 million. The Company ended the year 2006 with solid cash reserves of € 71 million. Lead compound Elocalcitol reached Phase II milestones in two key urological indications, with trials in a third indication scheduled for 2007. A second clinical stage asset acquired from Roche, BXL 746, is to be advanced into Phase II trials next year.
BioXell's healthy financial position and a modest cash burn rate estimated at € 17 million for 2007 put the Company in a strong position to advance the development of its clinical and preclinical phase assets while continuing to pursue strategic partnerships, in-licensing and M&A activities.
Francesco Sinigaglia, CEO of BioXell, commented, "2006 was an important year for BioXell during which we made substantial progress in the development of our pipeline. We reached key Phase II milestones for Elocalcitol, acquired new clinical and preclinical assets, and obtained scientific results that will lead to clinical trials in two new indications. With a successful IPO and additional private financing, combined with a disciplined cash burn rate, we ended the year on very solid financial footing. We are well situated to drive forward our clinical programs, maximize the potential of Elocalcitol and explore other opportunities to expand our pipeline."
BioXell also announced that it has now been added to the SWX Swiss Exchange's SXI LIFE SCIENCES and SXI Bio+Medtech indices, as of April 2, 2007. The full 2006 Annual Report is available and can be downloaded from the BioXell website at www.bioxell.com. Hardcopies will go out by regular mail at the end of next week.
R&D Highlights 2006 was a significant year for BioXell as the company delivered progress on multiple fronts, advanced its in-house programs, enriched its overall pipeline, and increased shareholder value.
* Elocalcitol reaches Phase II milestones in two key urological indications The clinical development of Elocalcitol in two major urological indications is proceeding on schedule. The completion in May 2006 of the Phase IIa trial of Elocalcitol in Overactive Bladder was a decisive milestone. The results indicated that BioXell's lead compound may have comparable efficacy to the "gold standard" anti-cholinergics in this indication, while avoiding the side effects typically associated with this class of products. In the first half of 2007 the Company will continue with a sophisticated "urodynamic" Phase IIb study, with results due in 2008. Meanwhile, in December 2006 enrolment was completed in the Phase IIb trial of Elocalcitol in Benign Prostatic Hyperplasia - the largest study ever conducted using MRI (Magnetic Resonance Imaging) to measure prostate volume. Results will be available in the second half of 2007. Success in either of these large indications will confirm Elocalcitol's blockbuster potential.
* Elocalcitol to enter clinical trials for Male Infertility A trial of Elocalcitol in Chronic Prostatitis that ended in 2006 showed no effect on the primary endpoint of pain reduction, but BioXell's scientists observed a significant reduction in the semen levels of IL-8, a marker of inflammation correlated with poor semen quality. A Phase II trial to study the effect of Elocalcitol on semen parameters is scheduled for the second half of 2007, potentially opening up a whole new therapeutic indication for this remarkable compound.
* BXL746 to enter clinical trials for Post-Surgical Adhesions BioXell acquired from Roche a second clinical stage asset, BXL746, which will be advanced into Phase II trials next year for Post-Surgical Adhesions. Following observations made while profiling BXL746 in a number of inflammatory conditions, BioXell's scientists confirmed the compound's efficacy in reducing adhesion formation in animals. Adhesions are an extremely frequent, unpleasant and painful complication of surgery, and the medical need for avoiding them is substantial.
* Preclinical pipeline Two other preclinical projects are moving along nicely. MNAC13, a fully humanized antibody acquired from Lay Line Genomics in late 2005, represents an exciting and innovative new approach to treating chronic and acute pain that may avoid the drawbacks of current treatments. It is currently being further characterized pharmacologically in-house in anticipation of its advancement into clinical trials. Meanwhile, BioXell's collaboration on the TREM platform with Merck & Co. is continuing on schedule, focusing on TREM-1 as a means of preventing Sepsis - a massive infection that is the primary cause of hospital deaths in emergency care units.
2006 Financial Highlights * € 40 million raised through a listing on the SWX Swiss Exchange in June * € 10.5 million in equity raised in a private financing round in March * Cash reserves of € 71 million at year-end * Cash burn of € 14. million for 2006 (vs € 7.5 million in 2005), reflecting an increase in R&D activities to € 12.4 million (vs € 9.4 million in 2005) * Net loss of € 13.8 million
Revenues Total revenues in 2006 amounted to € 2.5 million. BioXell currently derives revenues from its collaboration with Merck & Co., which accounted for € 1.7 million in 2006, and from research grants.
Operating expenses Total operating expenses in 2006 were € 17.9 million versus € 13.6 million in 2005, an increase of 32%. BioXell is channelling most of its operating expenses (69%) into the development of its R&D pipeline.
Total R&D expenses amounted to € 12.4 million versus € 9.4 million in 2005, an increase of 32% largely due to the increase in clinical trial costs for Elocalcitol - which completed enrolment of a 500+ patient trial in Italy and Germany - as well as the costs associated with the acquisition and development of MNAC13 and BXL746.
General and Administrative expenses were € 5.5 million, representing 31% of total operating expenses. These included mainly General Management, Business Development, Information Technology and Communications.
Net Loss The Company recorded a total net loss of € 13.8 million in 2006.
Balance sheet As a result of the IPO, and considering the net loss for the year, total shareholders' equity grew, as of December 31, 2006, to € 66.2 million versus € 33.9 million in the previous year, an increase of 95%. The Company ended the fiscal year with € 71 million in cash and investment securities, and maintained € 3.5 million in debt, a result of public financing on favourable terms.
Financial outlook BioXell expects a monthly cash burn rate of € 1.4 million in 2007 - in the vicinity of € 17 million for the year - as it continues to expand its R&D activities. In particular, 2007 will see the completion of a Phase IIb trial of Elocalcitol in BPH, the start of a Phase IIb trial of Elocalcitol in OAB, and the start of a Phase IIa trial of Elocalcitol in Male Infertility. The Company is exercising strong financial discipline as it makes maximum use of its resources to fund the advancement of its pipeline.
Additional information is available on the BioXell website at www.bioxell.com.
About BioXell BioXell (SWX: BXLN) is a biopharmaceutical company focused on the discovery and development of drugs that exploit novel mechanisms of action to treat important urological, inflammatory, and related disorders with significant unmet medical needs. The Company was founded in 2002 as a spin-out from Roche. BioXell's strategic goal is to become a fully integrated pharmaceutical company by maximizing the commercial potential of its product portfolio and leveraging existing platforms into profitable partnerships.
BioXell's lead compound, Elocalcitol, derived from its proprietary VD3 (Vitamin D3) technology platform, is in Phase II clinical trials for Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB), with a third Phase II trial for Male Infertility scheduled for 2007. In addition, the Company has several follow-on programs based on both VD3 and other technological platforms. BXL746 is to enter Phase II trials for Post-Surgical Adhesions in 2008. In late 2005, BioXell in-licensed from Lay Line Genomics S.p.A. a novel anti-TrkA monoclonal antibody, MNAC13, which represents an innovative new approach to the treatment of pain. BioXell also has an exclusive partnership with Merck & Co., Inc. since 2005 for the development of its TREM platform, with TREM-1 in development for the treatment of septic shock.
In June 2006, BioXell listed its shares on the main segment of the SWX Swiss Exchange. BioXell currently employs 60 people and has sites in Milan, Italy and Nutley, NJ, USA. More information on BioXell can be found at: http://www.bioxell.com
Please see the attachment for the complete press release. For further information, please contact:
BioXell S.p.A. Rochat & Partners Alvise Sagramoso/Angela Evans Christophe Lamps/Jonathan Leighton Tel: +39 (0)2 210 49 51 Tel: +41 22 718 37 46 Fax: +39 (0)2 210 49 529 Fax: +41 22 786 54 58 alvise.sagramoso@bioxell.com clamps@rochat-pr.ch angela.evans@bioxell.com jleighton@rochat-pr.ch
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